"The FDA clearly wants to see more safety data, but the good news for us is that we are still designing our phase III trials, so we can include the recommendations of the [Intrinsa] panel into our protocol," says Simes. He adds that any delay in the start of the LibiGel phase III studies will be measured in months, not years.
Could this be wishful thinking? Certainly. One of the panel members reviewing Intrinsa's safety, Dr. Steven Nissen, a cardiologist at Cleveland Clinic, suggested that adequate safety data would only come after studying Intrinsa's use in thousands of women, maybe tens of thousands of women. These are hugely expensive and time-consuming studies typically required for drugs like cholesterol-lowering statins.
The FDA has been stung by sharp criticism that it is too lax on drug safety, especially following
withdrawal of Vioxx from the market. So, it's not out of the realm of possibility to see the agency take a hard line with Proctor & Gamble about Intrinsa safety data.
Bottom line: Until Proctor & Gamble meets with the FDA to hammer out the exact safety requirements for Intrinsa, BioSante's plans for LibiGel will also be on hold. And even if BioSante manages to get its phase III studies started relatively soon, the added burden of collecting more safety data could stretch out completion of the trials for many more months, if not years.
Simes says he's hopeful that BioSante will be able to piggyback on any safety data collected by Proctor & Gamble -- and make BioSante's task less onerous -- because testosterone, whether it enters the bloodstream via a patch (with Intrinsa) or through a gel application (with LibiGel), will have the same effect on a woman's body.
To date, BioSante has been determined to develop LibiGel on its own, in order to maximize the potential for the product to its shareholders. But Thursday's setback could force the company to raise more money to pay for larger, lengthier studies, or partner LibiGel with a larger company at less ideal terms.
It needs to be noted that BioSante is not a one-trick pony. The company does have other hormone therapy products in development, including an estrogen gel for women. Bio-E-Gel is wrapping up a pivotal phase III study and should be filed with the FDA in the middle of 2005. Unlike LibiGel, Bio-E-Gel shouldn't run into unexpected regulatory delays because similar products are already on the market.
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